This study will focus on patients having inferior vena cava (IVC) thrombosis, either with or without thrombosis in other veins. The purpose of this study is to assess risk factors, safety and effectiveness of treatment options, and outcomes of patients with IVC thrombosis.
Thrombosis of the inferior vena cava (IVC) is a rare form of deep venous thrombosis (DVT). Optimal treatment strategies and clinical outcomes are not well established. This multicenter, international, observational study will assess the effectiveness and safety of current treatment options in patients with IVC thrombosis, and describe the long-term outcomes of patients with IVC thrombosis. Patients with an objective diagnosis of IVC thrombosis, either with or without proximal lower extremity DVT will be included. Information will be collected on baseline characteristics, risk factors for thrombosis, symptoms, mode of diagnosis, presence of concomitant lower limb DVT, PE, IVC filter or unusual site thrombosis (splanchnic, gonadal and renal veins), treatment modalities (anticoagulation and/or thrombolysis), choice of anticoagulant, dose and duration of treatment, recanalization assessment (if available), recurrence of VTE during follow up, bleeding according to International Society on Thrombosis and Haemostasis criteria, development post-thrombotic syndrome (PTS) according to Villalta score and mortality during follow up. Patients should be followed up for 24 months from diagnosis. The number of visits is left to the discretion of the treating physician, but information on clinical outcomes at two intermediate time points is requested.
Study Type
OBSERVATIONAL
Enrollment
200
Rates of venous thromboembolism (VTE) recurrence
Recurrence of any venous thrombosis (not previously diagnosed)
Time frame: 2 Years
Rate of all cause mortality
Mortality (patient's death) from any cause
Time frame: 2 Years
Rates of major bleeding
Major bleeding per International Society on Thrombosis and Haemostasis criteria Schulman S, Kearon C, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non-surgical patients. J Thromb Haemost 2005; 3: 692- 4.
Time frame: 2 Years
Rates of thrombosis recanalization
Evidence of thrombosis resolution by imaging (none/partial/complete, with regard to the latest imaging study), with time from initiation of therapy to thrombus resolution being calculated accordingly.
Time frame: 2 Years
Rates of post-thrombotic syndrome (PTS)
According to: Goldenberg NA, Brandão L, Journeycake J, Kahn S, Monagle P et al. Definition of post-thrombotic syndrome following lower extremity deep venous thrombosis and standardization of outcome measurement in pediatric clinical investigations. J Thromb Haemost. 2012 Mar;10(3):477-80.
Time frame: 2 Years
Rates of clinically relevant non-major bleeding
Clinically relevant non-major bleeding per International Society on Thrombosis and Haemostasis criteria Kaatz S, Ahmad D, Spyropoulos AC, Schulman S, Subcommittee on Control of Anticoagulation of the Scientific and Standardization Committee of the International Society on Thrombosis and Haemostasis. Definition of clinically relevant non-major bleeding in studies of anticoagulants in atrial fibrillation and venous thromboembolic disease in non-surgical patients: communication from the SSC of the ISTH. J Thromb Haemost. 2015 Nov;13(11):2119-26.
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Time frame: 2 Years